ORIC-114 in Combination with Subcutaneous Amivantamab in Patients with EGFR Exon20 Insertion Mutant NSCLC

Launched by ORIC PHARMACEUTICALS · Feb 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ORIC-114 in combination with a medication called amivantamab for patients with advanced lung cancer known as non-small cell lung cancer (NSCLC) that has a specific genetic mutation called EGFR exon 20 insertion. The goal of the trial is to find the best dose of these medications, understand how they work in the body, and see if they can help shrink tumors. Researchers are currently looking for participants who have this type of lung cancer, whether they have received treatment before or are starting treatment for the first time.

To be eligible for the trial, participants must have a confirmed diagnosis of metastatic NSCLC with the EGFR mutation and must be willing to undergo a biopsy for testing. They should also have measurable disease and good overall health. Importantly, people with certain conditions, like a history of specific lung diseases or certain types of cancer, may not be able to participate. Those who join the trial can expect close monitoring and follow-up to assess the safety and effectiveness of the treatment. This trial is an important step toward finding better options for patients with this challenging form of lung cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically or cytologically confirmed metastatic NSCLC with a documented EGFR exon 20 insertion mutation as determined locally by any nucleic acid-based diagnostic testing method; all tests should be performed in a CLIA certified or equivalently accredited laboratory
• * Prior Therapies:
• • 1. Dose Escalation: Patients may have previously received and progressed on or after platinum-based chemotherapy or may be treatment naïve
• • 2. Dose Expansion: Patients must not have received any prior therapy; at time of enrollment, patients must decline, or be ineligible for all available standard of care therapies with proven benefit
• • Agreement and ability to undergo a pretreatment biopsy, provided the procedure is clinically feasible and not deemed unsafe by the investigator
• • Measurable disease according to RECIST 1.1
• • Patients with asymptomatic CNS metastases are eligible
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• • Adequate organ function
• Exclusion Criteria:
• • Known small cell lung cancer transformation
• • Leptomeningeal disease
• • Spinal cord compression not definitively treated with surgery or radiation
• • Prior immunotherapy
• • Past medical history of interstitial lung disease (ILD), drug induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
• • Active gastrointestinal disease (eg, Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would reasonably impact absorption of ORIC-114